On 25 June, the President of Karolinska Institutet made the decision to find seven researchers responsible for scientific misconduct in research. The case concerns six articles published in the scientific journals The Lancet, Biomaterials, The Journal of Biomedical Materials Research and Thoracic Surgery Clinics. Paolo Macchiarini is one of the main authors of the articles.

The research reported in the articles relates to the transplantation of synthetic tracheal prostheses and describes the clinical course of treatment of three patients who were transplanted at Karolinska University Hospital 2011–2013. According to the President's decision, an additional 31 authors are blameworthy for their contributions to the articles, however not responsible for scientific misconduct. Another five authors are cleared of blame and of responsibility for scientific misconduct. Karolinska Institutet is requesting that the six articles be retracted without undue delay.

Today's decision was made following a new investigation of the six articles, and overturns the decision made on 28 August 2015 by the President at the time. The case was reopened in February 2016.

Serious inaccuracies in the articles

The new investigation points to serious inaccuracies and misleading information in the reviewed articles. The articles contain fabricated and distorted descriptions of the patients’ conditions before and after the operations. Justification is lacking for treatment of the patients on the grounds of so-called vital indication (when a given treatment is the last resort for survival), and one misses reference to relevant animal experiments which must precede human studies that involve unproven methods. Furthermore, ethical approvals are lacking, as are appropriate informed consents.

“This decision has been made after careful investigations in a case that has had major impact on Karolinska Institutet, on the scientific community at large, and on public confidence in medical research. In particular, the case has had tragic consequences for patients and their relatives, for which I am deeply sorry. Karolinska Institutet will now continue to implement the measures that are necessary to prevent something like this from happening again,” says Ole Petter Ottersen, President of Karolinska Institutet.

Whistle blower found responsible for misconduct

One of the authors that was found responsible for misconduct was among those who blew the whistle on Macchiarini in 2014.

“The investigation points to inaccuracies for which Paolo Macchiarini is ultimately responsible but for which several of the co-authors also bear responsibility. The four whistle blowers are to be commended for their action in this case that has contributed to the investigation. However, it is KI:s firm opinion that a whistle blower who has participated in a scientific study and also as author of a scientific article, despite reporting, cannot be freed from blame or absolved from responsibility”, says Ole Petter Ottersen.

According to Chapter 1, § 16 of the Higher Education Ordinance, a university that becomes aware of suspected scientific misconduct at said institution is obliged to investigate. In the course of an ongoing investigation, the higher education institution may solicit the opinion of the Expert group for misconduct in research at the Central Ethical Review Board, CEPN. According to KI procedure, suspected scientific misconduct is to be reported to the president of the university, and the president shall initiate an investigation and make a decision in the case.

The university where the research was conducted has an obligation to investigate suspected scientific misconduct even if all the involved researchers are not employed at or affiliated to that university.

Today's decision differs from the report of the Expert group for misconduct in research at the Central Ethical Review Board, CEPN, who considers all authors responsible for scientific misconduct. Karolinska Institutet's investigation has examined the responsibility of each individual author (a total of 43 researchers).

Only a few of the authors are currently employed at or affiliated to Karolinska Institutet.